Theravance Biopharma (TBPH) Affirms Filing of FF/UMEC/VI Submission with FDA for Use in COPD

November 21, 2016 4:39 PM EST

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Theravance Biopharma, Inc. (Nasdaq: TBPH) announced that GlaxoSmithKline plc (NYSE: GSK) and Innoviva, Inc. (Nasdaq: INVA) have filed a New Drug Application (NDA) in the U.S. for the Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol in a single ELLIPTA® inhaler) for patients with chronic obstructive pulmonary disease (COPD). The Closed Triple is one of the drug development programs for which Theravance Biopharma has an economic interest in future payments that may be made by GSK or one of its affiliates pursuant to its agreements with Innoviva (formerly Theravance, Inc.). Should the Closed Triple be approved and commercialized, Theravance Biopharma is entitled to receive an 85% economic interest in the royalties paid by GSK on worldwide net sales. Those royalties are upward-tiering from 6.5% to 10%. Additionally, Theravance Biopharma is not responsible for any costs related to the Closed Triple.

In an announcement made on November 21, 2016, GSK and Innoviva stated GSK has filed a regulatory submission with the U.S. Food and Drug Administration (FDA) for the once-daily, Closed Triple combination therapy. This follows the companies' announcement earlier this year of plans to pull forward the timing of the U.S. filing from the first half of 2018. The U.S. regulatory submission of the Closed Triple comprises an NDA for the maintenance treatment of patients with COPD, including chronic bronchitis and emphysema. It is based on data from the Closed Triple combination therapy development program, as well as data from studies with fluticasone furoate, umeclidinium, and vilanterol either alone or in combination. The announcement from GSK and Innoviva also noted that a regulatory filing in the E.U. is planned in the coming weeks and is expected to be followed by submissions in other countries beginning in 2017.

The Closed Triple combination therapy represents a unique approach to COPD treatment by seeking to combine the activity of three molecules with different mechanisms of action in a single, simple-to-use delivery device. The combination treatment includes: fluticasone furoate (FF), an inhaled corticosteroid; umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA); and vilanterol (VI), a long-acting beta2-adrenergic agonist (LABA). This combination has been formulated to be delivered once-daily in GSK's ELLIPTA® dry powder inhaler.

Current trends in the treatment of COPD with combination therapy support Theravance Biopharma's view that there is significant market potential for a first-in-class, once-daily Closed Triple. According to GSK, approximately one-third of COPD patients are already utilizing open triple therapy and the progressive nature of the disease indicates that COPD patients will need access to more effective therapies over time. Additionally, recently reported results from the Salford Lung Study, a Phase 3 real-world effectiveness trial of two of the components of Closed Triple (FF and VI) in COPD exacerbations, were strongly supportive of the benefits of once-daily therapy.

The ongoing clinical development program for the Closed Triple in COPD includes the IMPACT study, a large Phase 3 trial designed to evaluate the efficacy and safety of the triple combination treatment compared to dual COPD therapies (FF/VI and UMEC/VI). Results of the IMPACT study are expected to be reported by GSK in 20171.

The Closed Triple is also in development for the treatment of symptomatic asthma. A regulatory submission in this indication is planned for 2018 according to GSK.

Notes: 1 Regulatory and clinical milestones as reported by Glaxo Group Limited or one of its affiliates (GSK)

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